Medical Device Compliance Testing

IEC 62366, ISO 14971, & ANSI/AAMI HE75 require usability testing

“IEC 62366 specifies a process for a manufacturer to analyze, specify, develop, and validate the usability of a medical device as it relates to safety. . . . Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process.

It strengthens links to ISO 14971. . . . Part 2 [offers] more detailed descriptions of usability engineering methods that can be applied generally to medical devices.”

ANSI/AAMI HE75 Human Factors Engineering—Design of Medical Devices—provides comprehensive guidance on designing to accommodate user characteristics, managing the risk of use error, and undergoing usability testing to confirm the safety and effectiveness of the design. This document complements ANSI/AAMI/IEC 62366.

“FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments.”

UX Firm ensures compliance in Medical Device Testing

UX Firm is uniquely qualified to conduct usability testing of medical devices to ensure compliance with all regulations and guidelines. The experience of the partners, coupled with our hands-on approach to every research engagement, provides a complete testing process to produce actionable outcomes for product development teams.

Medical device testing flow diagram of usability services

For every phase of your planning and development process, we provide the right set of tools from our UX toolkit to gain insights into your users’ goals and context of use, building knowledge of user experience into all stages of product development from requirements gathering to the documentation of findings and recommendations against established criteria of safety, ease of use, and effectiveness of the design.

UX Firm has in-depth experience in user research with medical devices, which also extends to software used for insurance claims processing for physicians and recipients, studies around accessibility and universal design, and leading edge research using eye-tracking and fMRI.

Case Study Example

Study Goals

Gain insights into user experience of multiple product design prototypes to determine preferences, success/failure rates, and safety of use by caregiver, clinician, and patient populations.

Methodology

Structure a comparative usability evaluation of five prototypes with representative users from three population groups, using all versions of the prototype (in varied order) to determine human factors issues including safety and reliability as measured against a specific set of criteria.

Outcomes

A sample page from the report shows the results of one aspect of this testing. Two prototypes were determined to be the most successful and acceptable to the three user groups, with features from a third prototype reflecting some interest and acceptance from study participants. Recommendation was accepted to continue design and development of two prototypes to include the best features identified from this evaluation.

Retest took place in an iterative design process to determine improvements in success/acceptance in usability testing of more advanced models.

Client response

“[Our company] engaged UX Firm to conduct usability testing on our product in development. The study involved numerous concepts with different user groups and environments. UX Firm did an outstanding job conducting the study and analyzing the results in a timely fashion. They made relevant suggestions for device and labeling design changes to enhance user experience and safety. Their final presentation and report was professional and thorough.”

–Human Factors Evaluation Leader, R&D

Contact us to start the conversation about how we can help with your medical device compliance requirements.